Statin Therapy in Asymptomatic Aortic Stenosis

There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially dependent on typical cardiovascular risk factors. An inflammatory process as well as those risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase inhibitors) would be an appealing concept to reduce both those risks for development of aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the progression of aortic stenosis.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Drug: fluvastatin

Detailed Description

This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial trial to test the influence of statin therapy on the progression of calcified aortic stenosis in patients with asymptomatic mild to moderate aortic stenosis. After completion of all baseline investigations patients will be randomly assigned to the verum group (fluvastatin group) or to the control group (placebo group). Patients in the verum group will receive fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per day. The treatment should be continued until the study end (24 months). Follow up investigations will be performed after 6, 12, and 18 months. After 24 months the final investigations will be performed.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Claudia Walther, MD; Phone Number: xx49-341-8651428; Email: waltherc@medizin.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Recruiting
      • University of Leipzig - Heart Center
      • Contact: Claudia Walther, MD; Phone Number: xx49-341-8651428; Email: waltherc@medizin.uni-leipzig.de
      • Sub-Investigator: Claudia A Walther, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 21 years
2. Mild to moderate aortic stenosis
3. No symptoms caused by aortic stenosis
4. Written informed consent to participate in the study
5. Aortic valve leaflet thickening with reduced systolic opening
6. Reduced aortic valve area > 0,8 cm2 and < 1,5 cm2
7. Maximum aortic jet velocity at rest > 2,5 m/s

Exclusion Criteria:

1. Symptoms caused by aortic stenosis
2. Aortic valve area < 0,7 cm2
3. Severe aortic regurgitation
4. Reduced left ventricular ejection fraction (< 50%)
5. Any valve disease with indication for surgery
6. Coronary artery disease
7. Therapy refractory arterial hypertension
8. Comorbid noncardiac diseases or other reasons which make a regular follow-up impossible
9. Other indication for treatment with statins
10. Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
11. Known sensitivity to study drug(s) or class of study drug(s)
12. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
13. Use of any other investigational agent in the last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression of calcified aortic stenosis measured by:	24 months
Transthoracic echocardiography (P max/ mean; V max; AVA)	24 months
Catheterization (peak to peak gradient, LV-function, compliance)	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of cardiovascular events	24 months

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Novartis
• Investigators: Principal Investigator: Gerhard Schuler, Professor

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Anticipated): September 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): January 14, 2010
• Last Update Submitted That Met QC Criteria: January 13, 2010
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: aortic valve stenosis; statin therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: Leipzig aortic valve study